Continued Pressure for Alveolar Protection: A Randomized Controlled Trial (CPAP Trial)
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at 36 weeks' PMA.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 7 months
Healthy Volunteers: f
View:
• Gestational age \<29 weeks at birth
• PMA \<32 weeks at study entry
• On treatment with CPAP without a rate in FiO2 \<0.25 and PEEP of 4-5 cmH2O
• Meet stability criteria:
• If previously intubated must be extubated ≥ 72 hours
• \<3 self-resolving apneas (≤ 20 s) and/or bradycardia (\<100 bpm) in any hour over previous 6 hours
• No episodes of apnea or bradycardia requiring intervention (oxygen/stimulation/bag and mask) for 24 hours
• Parents/legal guardians consent for enrollment
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
California
Stanford University
RECRUITING
Palo Alto
Sharp Mary Birch Hospital for Women & Newborns
RECRUITING
San Diego
Georgia
Emory University
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Northwestern Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Mississippi
University of Mississippi Medical Center - Children's of Mississippi
RECRUITING
Jackson
North Carolina
Duke University
RECRUITING
Durham
New Mexico
University of New Mexico
RECRUITING
Albuquerque
Ohio
Cincinnati Children's Medical Center
RECRUITING
Cincinnati
Case Western Reserve University, Rainbow Babies and Children's Hospital
RECRUITING
Cleveland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Texas
University of Texas Southwestern Medical Center at Dallas
RECRUITING
Dallas
University of Texas Health Science Center at Houston
RECRUITING
Houston
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Colm P. Travers, MD
cptravers@uabmc.edu
205-934-3100
Backup
Abhik Das, PhD
adas@rti.org
301-230-4640
Time Frame
Start Date: 2026-11-05
Estimated Completion Date: 2029-01-30
Participants
Target number of participants: 860
Treatments
Experimental: Continuous Positive Airway Pressure
CPAP will be provided via mask or binasal prongs to maintain a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery whenever available.
Active_comparator: Nasal Cannula
HFNC at 4 L/min will be used initially in the control group. Flow should be titrated down by 1 L/min per day until ≤0.5 L/kg among infants in the nasal cannula group if not meeting pre-specified failure criteria to reduce the risk of inadvertent positive end-expiratory pressure (PEEP). Flow can also be increased (up to 6 L/min maximum) if needed among infants on NC who meet the pre-specified failure criteria. Infants in the control group placed back on CPAP may use an interface at provider discretion.
Related Therapeutic Areas
Sponsors
Leads: NICHD Neonatal Research Network
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)